MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE VERSATIE SYSTEM; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number 8450001

Device Problem Material Rupture (1546)

Patient Problem Pain (1994)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for investigation therefore, root cause cannot be identified at this time.Labeling review: ¿patient education: the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." device still in-situ.

Event Description

It was reported patient was experiencing left side pain as per reporter, xray films identified left band ruptured and right band to be loosened.Patient has undergone a revision procedure where product was replaced with other manufacturers product.

Manufacturer Narrative

Updated section h3 to no product return.

Event Description

On (b)(6) 2019 a patient under went a posterior fixation procedure.On (b)(6) 2020 due to left sided pain and has come back now for pelvic fixation and mid thoracic fixation (with another company).When revising, the left sided band had ruptured on the clamp, making the rod unstable and the right hand sided had ¿loosened¿ which had the same result.

Manufacturer Narrative

The product was received the complaint was confirmed as a frayed band not broken.The root cause of the issue is unknown, but may be the result of excessive post operative activity, insufficient bone prep, excessive construct loading or excessive tension applied during placement.Surgeon follow up and review was completed.Labeling review: ".Contraindications the subject device is intended for use only as indicated.Contraindications include, but are not limited to: 7.Patients who are unwilling to restrict activities or follow medical advice." ".Warnings, cautions, and precautions these devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed.The risk of bending, loosening or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the patient is active, or if the patient is debilitated, demented, or otherwise unable to use crutches or other weight supporting devices.".

• Brand Name: NUVASIVE VERSATIE SYSTEM
• Type of Device: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 10123063
• MDR Text Key: 194127970
• Report Number: 2031966-2020-00119
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00887517794857
• UDI-Public: 887517794857
• Combination Product (y/n): N
• PMA/PMN Number: K161265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8450001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 06/05/2020; 06/05/2020
• Supplement Dates FDA Received: 06/05/2020; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8510260; 8510260
• Patient Outcome(s): Hospitalization